CTRI/2021/05/033871已完成2 期
Oral versus Parenteral anticoagulation in the prophylaxis and therapeutic management of thromboembolic disease in hospitalised patients with confirmed COVID-19 disease
Dhiraj Kumar0 个研究点目标入组 230 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Participants were enrolled after RT PCR-evidence of COVID-19 infection or radiological evidence of COVID-19 associated mild or moderate infection requiring hospitalisation.
- •2. Ages 25 to 75 years.
- •3. If mild infection (uncomplicated URTI without evidence of breathlessness or hypoxia [SpO2 >94% as defined by local guidelines), to be included if CHADSVASc2 score is >=2 if female, >=1 if male; D-dimer levels >500 ng/mL or have previous history of malignancy, deep vein thrombosis (DVT), systemic embolism or ischaemic events.
- •4. All patients with moderate infection (features of pneumonia with dyspnoea, hypoxia [SpO2 90-94%], respiratory rate >23/minute as defined by local guidelines) to be included regardless of CHADSVASC score and D-D-dimer levels.
- •5. Documented informed consent
排除标准
- •Severe disease (pneumonia with SpO2 <90% or respiratory rate >30/minute or severe respiratory distress) or critical illness (signs of shock, sepsis, multi-organ failure.
- •Chronic liver disease ((e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN.
- •Chronic kidney disease (eGFR <30 mL/min/1.73m2).
- •History of intracranial bleeding in the last 3 months.
- •Bleeding diathesis, active peptic ulcer disease.
- •Pregnancy or first postpartum week.
- •Refractory hypertension (SBP >180 mmHg).
- •Any other contraindication listed in the local labelling of enoxaparin and rivaroxaban
研究者
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